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Chloramphenicolusp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name ChloramphenicolUSP CAS No:

Batch No: CHL/ 030313 A. R. No 13/ FP/ CHL/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +18.2º Between +17.0° to +20.0°

5. pH 5.7 Between 4.5–7.5,

6. Crystallinity Complies Meets the requirements

7. Bacterial Endotoxins Test 0.05EU/ mg NMT 0.2 USP EU/ mg

8. Assay HPLC 99.32% 97.0% –103.0%

9. Melting Temperature 151º 149°–153°

.

Chloramphenicol ( INN)

Chloramphenicol- 2D- skeletal. svg

Chloramphenicol- 3D- vdW. png

Systematic ( IUPAC) name

2, 2- dichloro- N- [ 1, 3- dihydroxy- 1- ( 4- nitrophenyl) propan- 2- yl] acetamide

Clinical data

Trade names Pentamycetin, Chloromycetin[ 1]

AHFS/ Drugs. com monograph

MedlinePlus a608008

Licence data US FDA: link

Pregnancy

category

AU: A

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Topical ( eye drops) , by, IV, IM

Pharmacokinetic data

Bioavailability 75–90%

Protein binding 60%

Metabolism Liver

Biological half- life 1.6- 3.3 hours

Excretion Kidney ( 5- 15% ) , faeces ( 4% )

Identifiers

CAS Registry Number 56- 75- 7 Yes

ATC code D06AX02 D10AF03 G01AA05 J01BA01 S01AA01 S02AA01 S03AA08 QJ51BA01

PubChem CID: 298

DrugBank DB00446 Yes

ChemSpider 5744 Yes

UNII 66974FR9Q1 Yes

KEGG D00104 Yes

ChEBI CHEBI: 17698 Yes

ChEMBL CHEMBL130 Yes

Chemical data

Formula C11H12Cl2N2O5

Molecular mass 323.1320 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 6, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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